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UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic Implantable Cardiac Defibrillator Implant (UMBRELLA)

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ClinicalTrials.gov Identifier: NCT01561144
Recruitment Status : Terminated
First Posted : March 22, 2012
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center

Study Description
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Brief Summary:
The purpose of the study is to analyze the different patient profiles implanted with an Implantable Cardiac Defibrillator (ICD) in Spain (guidelines adoption) and the patient prognosis as a function of clinical profile, implant indication, arrhythmias incidence, treatments or device programming.

Condition or disease
Cardiomyopathies Cardiac Arrhythmias Cardiac Arrest

Detailed Description:
Umbrella is a prospective and retrospective cohort study.
Study Design
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Study Type : Observational
Actual Enrollment : 4648 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic ICD Implant
Study Start Date : August 2011
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. To assess the number of ventricular and atrial arrhythmias, and atrial fibrillation burden detected by ICD. [ Time Frame: End of the study, an expected duration of 5 years. ]

Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients inplanted with an Implantable Cardiac Defibrillator (ICD) according to guidelines.
Criteria

Inclusion Criteria:

  • Patients with a Medtronic Implantable Cardiac Defibrillator (ICD) according to guidelines.
  • Patients with CareLink home Telemonitoring System.

Exclusion Criteria:

  • Unwillingness or inability to sign study written informed consent and/or CareLink consent.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561144


Locations
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Sponsors and Collaborators
Medtronic Bakken Research Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01561144    
Other Study ID Numbers: UMBRELLA
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Keywords provided by Medtronic Bakken Research Center:
Defibrillators, Implantable
Cardiac arrhythmias
Heart Disease
Additional relevant MeSH terms:
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Cardiomyopathies
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes